A Phase 2 interventional study of Cabozantinib in Prostate Cancer, sponsored by Edwin Posadas, MD. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-27.
Sponsored by Edwin Posadas, MD · Phase 2, Interventional, and Treatment
This research study is being done to measure the clinical benefit associated with cabozantinib (XL184) in men who have prostate cancer that has spread to visceral organs (organs other than bone or lymph nodes) and no longer responds to initial hormonal (castration) therapy. This type of prostate cancer is called metastatic, castrate-resistant prostate cancer.
Cabozantinib (XL184), a multi-targeted tyrosine kinase inhibitor, has demonstrated a powerful clinical phenotype in men with metastatic castrate resistant prostate cancer (mCRPC) both before and after chemotherapy. This phenotype consists of rapid reduction in pain (when present) and improvement in bone scans that may or may not be accompanied by decrease in serum prostate specific antigen (PSA) concentrations. In previous studies of cabozantinib in advanced prostate cancer, patients with visceral disease have been excluded. Hence, this protocol creates a unique opportunity to define the activity of this disease in the population of men with visceral disease - a marker for poorer prognosis in mCRPC.
Primary Objectives:
- To assess the clinical benefit (complete response + partial response + stable disease) of cabozantinib in patients with mCRPC with visceral metastases.
Secondary Objectives:
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 17 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Edwin Posadas, MD is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
KEY INCLUSION CRITERIA
- mCRPC that includes visceral disease. Visceral metastatic disease is defined as solid organ infiltration that is not bone or lymph node metastases.
KEY EXCLUSION CRITERIA
Cabozantinib 60mg orally daily until disease progression
Drug: Cabozantinib
Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression.
Also known as: XL184
Clinical Benefit Rate From Cabozantinib (XL184)
Clinical benefit rate is defined as the combination of complete response, partial response, and stable disease as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by CT imaging and Prostate Cancer Working Group 2 (PCWG2) criteria. Complete response (CR) defined as disappearance of all target lesions; Partial response (PR) \>=30% decrease in som of diameters of target lesions (taking as reference the baseline), and stable disease, neither sufficient shrinkage to qualify for PR nor increase to qualify for progressive disease.
Time frame: Baseline to 12 weeks after starting therapy
Change in Number of Circulating Tumor Cells (CTC) in Response to Cabozantinib
Change in number of CTC from baseline at 12 weeks
Time frame: Baseline and 12 weeks
Number of Patients With NanoVelcro Appropriate for RNA in Circulating Tumor Cells
This is to provide a measure of feasibility using NanoVelcro to measure RNA in circulating tumor cells (CTC)
Time frame: 12 weeks
Change in Levels of Serum Hepatocyte Growth Factor (HGF) and Vascular Endothelial Growth Factor (VEGF) Concentration
Mean change from baseline in levels of HGF and VEGF
Time frame: 12 weeks
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4)
Each cycle is 28 days. Safety and tolerability was defined as related grade 3-4 AEs of doses of cabozantinib below 100 mg daily using common terminology criteria for adverse events (CTCAE)
Time frame: Every 2 weeks for first 3 Cycles and every 4 weeks thereafter for an expected average of 28 weeks.
Number of Patients With Evaluable Protein Content of Large Oncosomes From Baseline to First Documented Progression or Date of Death
This is a feasibility outcome to assess ability to measure protein content in large oncosomes in this population.
Time frame: From baseline until the date of first documented progression or date of death from any cause, whichever comes first, assessed for an expected average of 28 weeks.
| Milestone | Treatment (Cabozantinib) |
|---|---|
| Started | 17 |
| Completed | 16 |
| Not completed | 1 |
Clinical benefit rate is defined as the combination of complete response, partial response, and stable disease as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by CT imaging and Prostate Cancer Working Group 2 (PCWG2) criteria. Complete response (CR) defined as disappearance of all target lesions; Partial response (PR) \>=30% decrease in som of diameters of target lesions (taking as reference the baseline), and stable disease, neither sufficient shrinkage to qualify for PR nor increase to qualify for progressive disease.
| Participants | Treatment (Cabozantinib) |
|---|---|
| Clinical Benefit Rate From Cabozantinib (XL184) | 10 |
Change in number of CTC from baseline at 12 weeks
| CTCs/7.5 ml | Treatment (Cabozantinib) |
|---|---|
| Change in Number of Circulating Tumor Cells (CTC) in Response to Cabozantinib | 53.2 ± 217.8 |
This is to provide a measure of feasibility using NanoVelcro to measure RNA in circulating tumor cells (CTC)
| Participants | Treatment (Cabozantinib) |
|---|---|
| Number of Patients With NanoVelcro Appropriate for RNA in Circulating Tumor Cells | 16 |
Mean change from baseline in levels of HGF and VEGF
| pg/ml | Treatment (Cabozantinib) HGF Levels | Treatment (Cabozantinib) VEGF Levels |
|---|---|---|
| Change in Levels of Serum Hepatocyte Growth Factor (HGF) and Vascular Endothelial Growth Factor (VEGF) Concentration | -322.96 ± 1981.19 | 191.1 ± 302.1 |
Each cycle is 28 days. Safety and tolerability was defined as related grade 3-4 AEs of doses of cabozantinib below 100 mg daily using common terminology criteria for adverse events (CTCAE)
| Participants | Treatment (Cabozantinib) |
|---|---|
| AST increased | 4 |
| Alkaline phosphatase increased | 2 |
| Anemia | 1 |
| Corneal Epithelial Defect | 1 |
| Dehydration | 1 |
| Diarrhea | 1 |
| GGT increased | 1 |
| Hematuria | 1 |
| Hypertension | 1 |
| Hyponatremia | 2 |
| Lipase increased | 2 |
| Lymphocyte count decreased | 3 |
| Palmar-Plantar Erythrodysesthesia | 1 |
| Rectal Fistula | 1 |
This is a feasibility outcome to assess ability to measure protein content in large oncosomes in this population.
| Participants | Treatment (Cabozantinib) |
|---|---|
| Number of Patients With Evaluable Protein Content of Large Oncosomes From Baseline to First Documented Progression or Date of Death | 12 |
Collected over From signed consent up to 30 days after last treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Cabozantinib) | — | 14/17 (82.4%) | 17/17 (100%) |
| Event | Treatment (Cabozantinib) |
|---|---|
| AnemiaBlood and lymphatic system disorders | 3/17 |
| NauseaGastrointestinal disorders | 2/17 |
| Chest Pain- CardiacCardiac disorders | 1/17 |
| CholecystitisHepatobiliary disorders | 1/17 |
| ConfusionPsychiatric disorders | 1/17 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/17 |
| FeverGeneral disorders | 1/17 |
| HematuriaRenal and urinary disorders | 1/17 |
| KeratitisEye disorders | 1/17 |
| Rectal fistulaGastrointestinal disorders | 1/17 |
| Event | Treatment (Cabozantinib) |
|---|---|
| ALT increasedInvestigations | 17/17 |
| AST increasedInvestigations | 15/17 |
| Palmar-Plantar Erythrodysesthesia SyndromeSkin and subcutaneous tissue disorders | 13/17 |
| Alkaline Phosphatase increasedInvestigations | 11/17 |
| Lymphocyte Count DecreasedBlood and lymphatic system disorders | 11/17 |
| White Blood Cell DecreasedInvestigations | 11/17 |
| DiarrheaGastrointestinal disorders | 10/17 |
| GGT IncreasedInvestigations | 10/17 |
| HoarsenessRespiratory, thoracic and mediastinal disorders | 10/17 |
| HypoalbuminemiaMetabolism and nutrition disorders | 10/17 |
| Age, Continuous(years) | Treatment (Cabozantinib) |
|---|---|
| Median | 65 (50 to 80) |
| Sex: Female, Male(Participants) | Treatment (Cabozantinib) |
|---|---|
| Female | 0 |
| Male | 17 |
| Race (NIH/OMB)(Participants) | Treatment (Cabozantinib) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 16 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2013 to primary completion in Jul 2016, 38 months.
Results were first posted in Sep 2017, 1 year 2 months after primary completion.
Of 569 non-industry phase 2 interventional studies under Prostatic Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 84. This study's 38 months is below that.
Counting every sponsor, half of 666 studies reached it within 52 months; a quarter within 34 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cabozantinib
Edwin Posadas, MD